Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional servo and proportional control systems for temperature regulation, with no mention of AI or ML algorithms.

Therapeutic

Yes

The device provides an enclosed, temperature-controlled environment and infrared heat to neonates to help them with thermoregulation, critical care, and transition from the uterus, directly impacting their physiological well-being.

Diagnostic

No

The device is described as an infant incubator and warmer, providing a controlled environment for neonates. Its functions are therapeutic and supportive (temperature regulation, resuscitation, oxygen therapy) rather than diagnostic (identifying or characterizing a disease or condition). While it monitors temperature, this is for therapeutic control, not for diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components such as an infant incubator, infant warmer, canopy lifting system, heating source, mattress, electronic scale, oxygen control system, observation lamp, tray, and IV pole. The device's function is based on controlling temperature and providing heat through physical means. While it mentions a temperature control system which likely involves software, the core of the device is hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description clearly states the device is an infant incubator and warmer. Its primary function is to provide a controlled environment and heat to neonates for thermoregulation and support.
No Sample Analysis: There is no mention of the device analyzing any biological samples from the infant. Its operation is based on monitoring and controlling environmental factors (temperature, humidity) and providing external heat.

The device is a therapeutic and supportive medical device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.

Product codes (comma separated list FDA assigned to the subject device)

FMZ, FMT

Device Description

The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Neonates / Infants

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing was conducted including:

ES 60601-1:2006+A1:2012 Medical electrical equipment -- part 1: . general requirements for basic safety and essential performance.
. IEC 60601-1-2:2014 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
IEC 6060-1-8 General requirements for basic safety and essential . performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
IEC 60601-2-19 Particular requirements for the basic safety and . essential performance of infant incubators.
IEC 60601-2-21 Particular requirements for the basic safety and . essential performance of infant radiant warmers.
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: . Tests for in vitro cytotoxicity.
. ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
Guidance for Industry and FDA Staff, titled "Guidance for the Content . of Premarket Submissions for Software Contained in Medical Devices," issued on: May 11, 2005.
Guidance for Industry and Food and Drug Administration Staff titled . "Applying Human Factors and Usability Engineering to Medical Devices," issued on: February 3, 2016.
Guidance for Industry and Food and Drug Administration Staff ● titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," issued on March 17, 2015.

Clinical evaluation is not applicable for the proposed device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K993407

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.5400 Neonatal incubator.

(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 25, 2019

Ningbo David Medical Device Co., Ltd Lin Dingyu Vice General Manager No.2, Keyuan Road, Shipu Technology Park, Xiangshan Ningbo. 15731 China

Re: K190494

Trade/Device Name: Infant Incubator Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal incubator Regulatory Class: Class II Product Code: FMZ, FMZ, FMT Dated: October 23, 2019 Received: October 25, 2019

Dear Lin Dingyu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K190494

Device Name YP-3000 Infant Incubator

Indications for Use (Describe)

The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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3

K190494 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

1. Date Prepared [21 CFR 807.92(a)(1)]

November 22, 2019

2. Submitter's Information [21 CFR 807.92(a)(1)]

Company Name:	Ningbo David Medical Device Co., Ltd.
Company Address:	NO. 2, KEYUAN ROAD, SHIPU TECHNOLOGY PARK, XIANGSHAN, NINGBO, ZHEJIANG PROVINCE, P.R. China
Fax:	+86-574-87800008

Fax:

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:
Models:
Product Codes:
Regulation Number:
Regulation Name:
Device Class:

Infant Incubator YP-3000 FMZ, FMT 21 CFR 880.5400 Neonatal incubator Class II

4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification of the predicate device within this submission is as follows:

Manufacturer: Trade Name: Product Codes: Regulation Name: Regulation Number: FDA 510 (k) #:

OHMEDA MEDICAL. OmniBed FMZ, FMT Neonatal incubator 21 CFR 880.5400 K993407

5. Description of the Device [21 CFR 807.92(a)(4)]

4

The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.

6. Indications for Use [21 CFR 807.92(a)(5)]

The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.

7. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

| | YP-3000
Infant Incubator | OmniBed | Differences Discussion |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| State | Subject Device | Predicate Device | N/A |
| | | | |
| Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-19
IEC 60601-2-21
ISO 10993-5
ISO 10993-10 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-19
IEC 60601-2-21
ISO 10993-5
ISO 10993-10 | Same |
| Indications for
Use | The device is an infant
incubator and an
infant warmer. The
two functions can be
converted through the
canopy lifting system.
The incubator
provides an enclosed,
temperature-
controlled
environment and the
warmer provides
infrared heat in an
open environment.
The warmer provides
heat in a controlled
manner to neonates
who are unable to
thermoregulate based
on their own
physiology. The
incubator and warmer
may also be used for
short periods of time
to facilitate a
neonate's transition
from the uterus to the
external environment. | The OmniBed is a
combination of an
infant incubator
(incubator) and an
infant warmer
(warmer). Incubators
and warmers provide
heat in a controlled
manner to neonates
who are unable to
thermo-regulate
based on their own
physiology. Incubators
provide an enclosed,
temperature-
controlled
environment and
warmers provide
infrared heat in an
open environment.
They may also be
used for short periods
of time to facilitate the
neonate's transition
from the uterus to the
external environment. | Similar - same intended
use, users, and use
environment; minor
grammatical differences
and device trade name is
not mentioned. |
| Electrical Description | | | |
| Power supply | AC 220-230V/50Hz;
AC 110-120V/60Hz | 100V, 115V, 220V,
230V, 240V, 50/60Hz | Similar-1.
We performed safety tests
and performance tests
based on IEC 60601-1,
IEC 60601-2-19 and IEC |
| | | | 60601-2-21 standards to
cover both voltage ranges.
The test results
demonstrate that the
subject device YP-3000
met the standard
requirements, so this
difference does not raise
new questions of safety
and effectiveness. |
| Maximum
current/ power
consumption | 1300VA | ≈1100VA | Similar-2.
We conducted safety tests
and performance tests
based on the IEC 60601-1
standard. The test results
demonstrate that the
subject device YP-3000
met the standard
requirements, so this
difference does not raise
new questions of safety
and effectiveness. |
| Electrical safety | According to IEC
60601-1 | According to IEC
60601-1 | Same |
| Principles of Operation | | | |
| General | Radiant Warmer and
Infant Incubator | Radiant Warmer and
Infant Incubator | Same |
| Control Modes | Incubator mode;
Warmer mode | Incubator mode;
Warmer mode | Same |
| Probe Type &
Connectors | Air temperature
sensor | Air temperature
sensor | Same |
| | Skin temperature
sensor | Skin temperature
sensor | Same |
| | air flow temp. sensor | air flow temp. sensor | Same |
| | O2 Sensors | O2 Sensors | Same |
| | Humidity Sensor | Humidity Sensor | Same |
| | Isolated air
temperature sensor | Isolated air
temperature sensor | Same |
| | Multi-port connector
connects 2 | Multi-port connector
connects 2 | Same |
| | transducers | transducers | |
| | RS232 connector | RS232 connector | Same |
| Warmer Operation | | | |
| Warmer | Radiant Warmer | Radiant Warmer | Same |
| Temperature
Control Modes | Pre-warm mode;
Manual mode;
Baby mode (Baby
temperature
control) | Manual mode;
Baby mode;
(Pre-warm mode); | Same |
| Temperature
Control Range
Under the Skin
temp. Mode | 34.5°C37.5°C in 0.1
increments | 3537.5°C in 0.1
increments | Similar-3.
Compared with the
predicate device, the
temperature control range
of the subject device YP-
3000 is slightly wider, and
under this temperature
control range, the
temperature control
accuracy of the device, the
consistency of the bed
temperature and the
predicate device are
equivalent. This control
range satisfies the
requirements of
201.15.4.2.2.101 of
IEC60601-2-21. This
difference does not raise
new questions of safety
and effectiveness. |
| Difference
Between Skin
Temperature
Sensor and
Control
Temperature | ≤0.5°C | ≤0.5°C | Same |
| Temperature
Uniformity of
Bed Surface | ≤2°C | ≤2°C | Same |
| Incubator Operation | | | |
| Heater | Convective heater | Convective heater | Same |
| Modes under the
incubator mode | Air mode;
Baby mode | Air mode;
Baby mode | Same |
| Air Temperature
Control range | 2539℃ in
0.1increments | 2039℃ in 0.1
increments | Similar-4.
Neonatal patients in the
ambient temperature
should not be less than 25
℃, so YP-3000 product air
control temperature range
is designed to 25℃39℃.
Under this temperature
control range, the
temperature control
accuracy, temperature
stability and predicate
equipment of the
equipment are equivalent.
This control range satisfies
the requirements of
201.15.4.2.2.101 in
IEC60601-2-19. Therefore,
this difference does not
raise new questions of
safety and effectiveness. |
| Skin
Temperature
Control range | 3438℃ in 0.1
increments | 3537.5℃ in 0.1
increments | Similar-5.
The comparison with the
predicate device, YP-
3000's temperature control
range is slightly wider, and
under this temperature
control range, the
temperature control
accuracy, temperature
stability and predicate
equipment of the device
are all equivalent. This
control range satisfies the
requirements of
201.15.4.2.2.102 in |
| | | | |
| | | | IEC60601-2-19. Therefore,
this difference does not
raise new questions of
safety and effectiveness. |
| Temperature
Rise Time | ≤40min | 85% | Similar-9.
Based on the analysis of
the humidity control range,
this indicator indicates the
deviation range between
the actual humidity and the
control value in the
incubator during humidity
control, the humidity
control precision of subject
device YP-3000 is better
than the predicate device,
so this difference does not
raise new questions of
safety and effectiveness |
| Oxygen
Concentration
Control Range | 20% O₂60% O₂ | 21% O₂~65% O₂ | Similar-10.
In general, the
concentration of oxygen in
the nature atmosphere is
about 20.9%. Compared
with the predicate device,
the oxygen concentration
control range of YP-3000
is included in the oxygen
concentration control range of the predicate
device, the oxygen
concentration range is
verified to meet the design
requirement, so this
difference does not raise
new questions of safety
and effectiveness. |
| Oxygen
Concentration
Control
Precision | ±4% O₂ | ±5% O₂ | Similar-11.
Based on the analysis of
the oxygen concentration
control range, this index
indicates the deviation
range between the actual
oxygen concentration in
the incubator and the
control value during
oxygen concentration
control. The oxygen
concentration precision is
verified to meet the design
requirement and is slightly
different to predicate
device. This difference
does not raise new
questions of safety and
effectiveness. |
| Carbon dioxide
(CO2)
Concentration
Inside the Hood
Under Incubator
Mode | 38°C (SET≤37°C)

40°C (SET>37°C) | Similar-16.
Both the subject device
and predicate device meet
the requirements of
201.15.4.2.1 aa) of IEC
60601-2-19, so this
difference does not raise
new questions of safety
and effectiveness. |
| Skin Overheat
Alarm | The temperature
measured by skin
temperature sensor | Not provided | Similar-17.
Both the subject device
and predicate device meet |
| | under the warmer
mode is over 38.5°C | | the requirements of
201.15.4.2.1 bb) of IEC
60601-2-19, so this
difference does not raise
new questions of safety
and effectiveness. |
| Water Shortage | Water tank is lacking
water | Water tank is lacking
water | Same |
| Operating Condition Description | | | |
| Temperature | +20~+30°C | +20~+30°C | Same |
| Humidity | 30%75%RH | 10% to 95% RH | Similar-18.
Under the specified
working conditions,
whether the safety and
effectiveness of the
product can be guaranteed
depends on the product
itself and cannot be
concluded through data
comparison. Therefore, we
provide an environmental
test report to prove that the
subject device YP-3000
can work normally under
this operation condition, so
this difference does not
raise new questions of
safety and effectiveness. |
| Storage Condition Description | | | |
| Temperature | -20+55°C | -25~+60°C | Similar-19.
Under the specified
working conditions,
whether the safety and
effectiveness of the
product can be guaranteed
depends on the product
itself and cannot be
concluded through data
comparison.
Environmental testing
supports that the subject
device YP-3000 performs
as intended under this
operation condition, so this
difference does not raise
new questions of safety
and effectiveness. |
| Relative
humidity | ≤93%RH | ≤95%RH | Similar-20.
Under the specified
working conditions,
whether the safety and
effectiveness of the
product can be guaranteed
depends on the product
itself and cannot be
concluded through data
comparison. Therefore, we
provided environmental
testing report to support
that the subject device YP-
3000 works normally under
this operation condition, so
this difference does not
raise new questions of
safety and effectiveness. |

5

6

7

8

9

10

11

12

13

14

15

Discussion of Substantial Equivalence:

Comparison of Product performance, Power Supply, Operating Conditions, and Storage Conditions between the predicate device and the proposed device, YP-3000, identified minor differences with the Predicate Device OmniBed; the differences were supported with performance testing, as appropriate, and do not raise new questions of device safety and effectiveness. The proposed device YP-3000 has similar indications for use; the technological characteristics differences listed in the above table between

16

the proposed device YP-3000 and the predicate device OmniBed do not raise any new questions of safety and effectiveness.

Non-Clinical Testing:

The following bench testing was conducted in order to support substantial equivalence:

ES 60601-1:2006+A1:2012 Medical electrical equipment -- part 1: . general requirements for basic safety and essential performance.
. IEC 60601-1-2:2014 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
IEC 6060-1-8 General requirements for basic safety and essential . performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
IEC 60601-2-19 Particular requirements for the basic safety and . essential performance of infant incubators.
IEC 60601-2-21 Particular requirements for the basic safety and . essential performance of infant radiant warmers.
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: . Tests for in vitro cytotoxicity.
. ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
Guidance for Industry and FDA Staff, titled "Guidance for the Content . of Premarket Submissions for Software Contained in Medical Devices," issued on: May 11, 2005.
Guidance for Industry and Food and Drug Administration Staff titled . "Applying Human Factors and Usability Engineering to Medical Devices," issued on: February 3, 2016.
Guidance for Industry and Food and Drug Administration Staff ● titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," issued on March 17, 2015.

Clinical Testing:

Clinical evaluation is not applicable for the proposed device.

8. Conclusion [21 CFR 807.92(b)(3)]

Based on the performed testing per the standards above and comparison of technological characteristics with the predicate device, the YP-3000 Infant

17

Incubator is substantially equivalent to the predicate device. It does not introduce a new intended use and has equivalent technological characteristics. The differences from the predicate do not introduce any new potential hazards or safety risks.